Clinical trials: Therapeutic Equivalency
Healthy
Food Study of Glipizide and Metformin HCl Tablets 5 mg/500 mg to Metaglip® Tablets 5 mg/500 mg
The objective of this study was to investigate the bioequivalence of Mylan's glipizide and metformin HCl 5 mg/500 mg tablets to Bristol-Myers Squibb's Metaglip® 5 mg/500 mg tablets following a single, oral 5 mg/500 mg (1 x 5…
- Trial name
- NCT00648505
- Testing
- Glipizide and Metformin HCl Tablets 5 mg/500 mg, Metaglip® Tablets 5 mg/500 mg
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy Postmenopausal Females
Bioequivalence of Nomegestrol Acetate (NOMAC) and Estradiol (E2) in Commercial Versus Phase 3 Pivotal Clinical Batches of NOMAC-E2 Tablets (P06328)
For the contraceptive application a film-coated tablet has been developed which combines nomegestrol acetate (NOMAC) with estradiol (E2).
- Trial name
- NCT01345786
- Testing
- Commercial NOMAC-E2, Phase 3 NOMAC-E2 "Batch A", Phase 3 NOMAC-E2 "Batch B"
- Volunteers
- 158 people, healthy volunteers welcome
- Sponsor
- Organon and Co
Healthy Volunteers, Overweight
A Research Study Looking at the Comparability (Bioequivalence) of Two Versions of Semaglutide
The study will look at how two different versions of semaglutide reach and stay in the blood after injection. The study aims to show similar levels of semaglutide in the blood when using the different versions.
- Conditions
- Healthy Volunteers, Overweight, Obesity
- Trial name
- NCT04228354
- Testing
- Semaglutide
- Where
- Germany
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Treatment of Overactive Bladder
A Bioequivalence Study Of 8 Mg Fesoterodine Extended-Release Tablets (Toviaz™) In Healthy Subjects
This bioequivalence (BE) study is to satisfy FDA regulatory requirements for extended releases drug product transfer from Zwickau, Germany to Vega Baja, Puerto-Rico.
- Trial name
- NCT00902681
- Testing
- Fesoterodine
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Bioequivalence Study of Levothyroxine Sodium Tablets 100 mcg
The objective of this study is to establish the bioequivalence of two levothyroxine formulations through the estimation of T4 levels in serum samples after baseline correction, according to Food and Drugs Administration (FDA)…
- Trial name
- NCT04573907
- Testing
- Drug Levothyroxine 100 mcg, Drug Eutirox 100 mcg
- Where
- Argentina
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Tecnoquimicas
Therapeutic Equivalency
A Study To Determine Bioequivalence Between The Commercial Femulen Tablets And A Reformulation Of Femulen Tablets In Healthy Female Subjects
A pivotal study to determine bioequivalence between a the current marketed formulation of Femulen tablets and reformulated Femulen tablets in healthy female subjects.
- Trial name
- NCT01359163
- Testing
- etynodiol diacetate
- Where
- Singapore
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Pfizer
Diabetes, Healthy
Bioequivalence of Two Insulatard® Formulations in Healthy Subjects
This trial is conducted in Europe. The aim of this trial is to test for bioequivalence between two formulations of Insulatard® in healthy subjects.
- Trial name
- NCT01486901
- Testing
- isophane human insulin
- Where
- Germany
- Volunteers
- 44 people
- Sponsor
- Novo Nordisk A/S
Heartburn
A Study to Assess the Bioequivalence of Famotidine/Antacid Combination Tablets Compared to Famotidine/Antacid EZ Chew Tablets (0208C-145)(COMPLETED)
A study in 24 healthy subjects to assess the bioequivalence of Famotidine/Antacid EZ Chew tablet taken without water and with water compared to the Famotidine/Antacid tablet taken with water.
- Trial name
- NCT00944671
- Testing
- famotidine (+) calcium carbonate (+) magnesium hydroxide tablet, Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet without water, Comparator: famotidine (+) calcium carbonate (+) magnesium hydroxide EZ Chew tablet with water
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
Healthy
Bioequivalence Study of Meloxicam Capsules 15 mg (Mobic® Capsules 15 mg) Versus Meloxicam Tablets 15 mg (Mobic® Tablets 15 mg) in Healthy Adult Volunteers
Primary Objective: To access the bioequivalence of meloxicam capsule 15 mg (Test, T) to meloxicam tablet 15mg (Reference, R) following oral administration.
- Trial name
- NCT02183181
- Testing
- Meloxicam capsule, Meloxicam tablet
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy
Bioequivalence Study of Donepezil Hydrochloride 10 mg Tablets Under Fasting Conditions
This open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover study was conducted to compare the relative bioavailability of equal doses of the test and reference products under fasted…
- Trial name
- NCT01276067
- Testing
- Donepezil
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ranbaxy Laboratories Limited
Healthy Volunteers
A Clinical Study Comparing the Bioequivalence of IBI3027 and DUPIXENT®(Dupilumab) in Healthy Chinese Volunteers
This study is a multicenter, randomized, double-masked, parallel-group, reference-drug-controlled clinical trial of IBI3027 in healthy male volunteers.
- Trial name
- NCT07502534
- Testing
- IBI3027, DUPIXENT® (dupilumab)
- Where
- China
- Volunteers
- 180 people, healthy volunteers welcome
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Healthy
A Relative Bioavailability Study of 200mg/5 mL Azithromycin Oral Suspension Under Non-Fasting Conditions
The study will compare the relative bioavailability (rate and extent of absorption) of 200 mg/5 mL Azithromycin oral suspension manufactured by TEVA Pharmaceutical Industries Ltd.; distributed by TEVA Pharmaceuticals USA with…
- Trial name
- NCT00830336
- Testing
- Azithromycin, Zithromax®
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Opioid Overdose
A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder
A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Nasal Powder.
- Trial name
- NCT04713709
- Testing
- Nasus Pharma FMXIN001, Nasal Naloxone liquid spray
- Where
- Canada
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Nasus Pharma
Healthy
Fasting Study of Oxybutynin Chloride Extended-release Tablets 5 mg and Ditropan XL® Tablets 5 mg
The objective of this study was to investigate the single-dose relative bioavailability of Mylan's oxybutynin chloride Extended-release tablets to ALZA's Ditropan XL® tablets following a single, oral 20 mg (4 x 5 mg) dose under…
- Trial name
- NCT00650481
- Testing
- Oxybutynin Chloride Extended-release Tablets 5 mg, Ditropan XL® Tablets 5 mg
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Mylan Pharmaceuticals Inc
Healthy
Ramipril 10 mg Capsule in Healthy Subjects Under Fed Conditions
The objective of this study is to compare the rate and extent of absorption of Ramipril 10 mg capsule (test) versus Altace® (reference), administered as 1 x 10 mg capsule under fed conditions.
- Trial name
- NCT00829530
- Testing
- Ramipril 10 mg capsule, Altace® 10 mg capsule
- Where
- 2 sites in Canada
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Healthy
Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone Under Fasting Conditions in Healthy Volunteers
The purpose of this study is to assess the safety and bioequivalence of a single oral dose of carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa combination plus a single oral dose of…
- Trial name
- NCT00415844
- Testing
- ELC200 (carbidopa+levodopa+entacapone)
- Where
- Germany
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Novartis
Healthy
Bioequivalence Study of Letrozole 2.5 mg Tablets
Bioequivalence
- Trial name
- NCT01084499
- Testing
- Femara (Sequence 1), Peratra (Sequence 1), Femara (Sequence 2)
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Fed
Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fed Conditions
The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical status, adverse events and laboratory…
- Trial name
- NCT01505998
- Testing
- Amlodipine Besylate/Benazepril HCl
- Where
- India
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Type 2 Diabetes Mellitus
Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)
The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Dapagliflozin from a 2.5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral administration relative to 2.5-mg Saxagliptin and 5-mg…
- Trial name
- NCT02060201
- Testing
- Saxagliptin, Dapagliflozin, Saxagliptin/Dapagliflozin FDC
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
An Investigation Of The Absorption And Pharmacokinetics Of Multiple Doses Of A Controlled Release Pregabalin Tablet As Compared To Multiple Doses Of The Immediate Release Pregabalin Capsule In Healthy Volunteers
The purpose of this study is to 1)evaluate the extent of absorption of multiple doses of a pregabalin controlled release tablet as compared to multiple doses of the pregabalin immediate release capsule, 2) evaluate the…
- Trial name
- NCT01257516
- Testing
- Pregabalin immediate release, 300 mg, Pregabalin controlled release, 330 mg
- Where
- Belgium
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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